As pointed out in our publication entitled "Modular Formula: An Approach to Management of Infants with Specific or Complex Food Intolerances" published in Volume 88, No. 6 at pp. 948-952 of the Journal of Pediatrics, June, 1976, the basic modular components of an infant formula are protein, fat, carbohydrate, minerals, vitamins, and water. With existing proprietary infant formulas, the physician can not limit changes to one of the components when a new formula is desired but is obliged to change several of them. As an understanding of chronic diarrheal disease increases, it is becoming obvious that infants can develop complex intestinal intolerances. Carbohydrate malabsorption can be present simply as an intolerance to lactose or as an intolerance to all carbohydrates including glucose. A fermentative diarrhea results if the ingested sugar is not altered to correspond to the ability of the intenstine to absorb it. Chronic diarrhea may lead to a depletion of the bile acid pool (personal observation), causing maldigestion of long-chain fats. Specific protein hypersensitivity may go undetected because of the overlap of symptoms associated with other nutrient intolerances.
This publication discloses and sets forth a report of our early work in providing a modular formula (original module) comprised of protein in the form of calcium sodium caseinate and electrolytes which was usually used in a concentration of 3 gm of core mix per 100 ml of water which provides 2.2 gm of protein and essentially the same minerals found in most commercial formulas. As pointed out in this publication, the physician may add fat of any nature and in any quantity that he considers desirable with final concentrations ranging between 3.5 and 4.5 gm/100 ml, and the type and amount of carbohydrate to be added are determined by the gastrointestinal tolerance of the individual patient, with final concentrations ranging between 5 and 7 gm/100 ml.
We have found, however, that substantially improved results are obtained by significantly altering and improving the original modular or core formula disclosed in the above publication. This includes decreasing the dietary acid content, that is, chloride to a maximum of 2.0% dry weight, and providing a better and more effective array of minerals by providing a minimum of 1.0% dry weight phosphorus (improved module).
U.S. Pat. No. 1,302,436 to Dunham, discloses a preparation of a core formula composed of a mixture of casein and oil, which may be mixed with water to form a cream substitute, or added to milk to enrich the same; however, there is no mention made for a use of this preparation as a module or core formula and one particularly for infants.
U.S. Pat. No. 3,901,979 to Nagasawa, discloses a process for preparing a low sodium infant formula mixture containing a casein micelle to which may be added fat, emulsifier, carbohydrates and mineral nutrition elements such as vitamins.
U.S. Pat. No. 2,611,706 to Bernhart et al, shows a milk-based food product consisting of skim cow's milk, sodium caseinate, lactose and fat components as set forth in Table II.
U.S. Pat. Nos. 891,336; 1,450,836; and 1,607,844 discloses infant formulas containing four components such as casein, oil, carbohydrates and minerals.
U.S. Pat. Nos. 750,832 and 3,995,070 disclose processes for preparing food casein having a suggested utility in infant formulations.
U.S. Pat. Nos. 1,341,040; 1,557,053; 1,767,185; and 2,682,467 are of general interest and are representative of the state of the art.
Other references are of record in our prior applications.
None of the foregoing patents disclose the improved dietary food module or modular or core formula of the present invention by which advantageous results are obtained.